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TWIN-PASS DUAL ACCESS CATHETER
- Starting date:
- September 16, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-60548
Affected Products
Reason
Investigation of recent device experience reports has made Vascular Solutions, Inc. (VSI) aware of a potential problem with the Twin-Pass(5200), Twin-Pass RX (5210) and Twin-Pass .023" (5230) Dual Access Catheters. VSI has concluded there is a potential for excess manufacturing material to remain at the tip of the catheter or within the distal portion of the rapid exchange lumen. It is possible that the excess material may separate from the catheter during a procedure, which poses a potential risk of embolism to the patient.
Affected products
TWIN-PASS DUAL ACCESS CATHETER
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
5200
5230
Companies
- Manufacturer
-
Vascular Solutions Inc.
6464 Sycamore Court
Minneapolis
55369
Minnesota
UNITED STATES